UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055701 |
|---|---|
| Receipt number | R000063554 |
| Scientific Title | Study on health status assessment utilizing salivary biomarkers |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2024/10/02 10:49:00 |
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Basic information
Public title
Study on health status assessment utilizing salivary biomarkers
Acronym
Study on health status assessment utilizing salivary biomarkers
Scientific Title
Study on health status assessment utilizing salivary biomarkers
Scientific Title:Acronym
Study on health status assessment utilizing salivary biomarkers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm that health status can be evaluated utilizing salivary biomarkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Salivary biochemical test (hormone, cytokine)
(30 min before waking up, immediately after waking up, after waking up (30-60 min), after waking up (5h, 9h, 13h), before bedtime)
Key secondary outcomes
1.MCTQ(Munich ChronoType Questionnaire-Japanese version)
2. Nutritional intake status(FFQ)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Subjects employed at Nissin Pharma Co., Ltd., aged 20 years or older at the time of obtaining consent
(2) Subjects who have received a sufficient explanation of the study, are able to understand its contents, and can provide written consent
(3) Subjects who have not been diagnosed with sleep disorders or periodontal disease
Key exclusion criteria
(1) Subjects who are currently participating in clinical trials of other drugs or health foods, who are within 4 weeks of completing a clinical trial, or who plan to participate in another clinical trial after agreeing to participate in this study
(2) Subjects for whom it is difficult to collect saliva samples
(3) Subjects who the principal investigator judges to be inappropriate to participate in this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Fujita |
Organization
NISSHIN PHARMA INC.
Division name
HEALTH CARE RESEARCH CENTER
Zip code
356-8511
Address
5-3-1, Tsurugaoka, Fujimino-city, Saitama 356-8511, Japan
TEL
049-267-3940
kenkouken_pharma@nisshin.com
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Ohgo |
Organization
NISSHIN PHARMA INC.
Division name
HEALTH CARE RESEARCH CENTER
Zip code
356-8511
Address
5-3-1, Tsurugaoka, Fujimino-city, Saitama 356-8511, Japan
TEL
049-267-3940
Homepage URL
kenkouken_pharma@nisshin.com
Sponsor or person
Institute
NISSHIN PHARMA INC.
Institute
Department
Personal name
Funding Source
Organization
NISSHIN PHARMA INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
chiyoda paramedical care clinic, ethics review committee
Address
3-3-5 Yamawauchikanda2F, Uchikannda, Chiyoda-ku, Tokyo
Tel
03-5297-5548
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Implementation Period:
September 13, 2024-March 31, 2025
Registration period:
September 13, 2024-September 17, 2024
Follow-up period:
1 week
Type and Design of Study:
Observational study
Study Subjects:
Employees who are employed at Nisshin Pharma Co., Ltd. as of September 13, 2024.
Case Registration Method:
The principal investigator or researcher will obtain informed consent from the study subjects and determine their eligibility.
Planned Participation Period for Study Subjects:
Subjects will participate for a period of 1 week after giving consent.
Observation and Examination Items:
Salivary biochemical test (hormone, cytockine)
(30 min before waking up, immediately after waking up, after waking up (30-60 min), after waking up (5h, 9h, 13h), before bedtime)
MCTQ(Munich ChronoType Questionnaire-Japanese version)
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063554
